The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study

This study has been completed.
Sponsor:
Information provided by:
Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT00821067
First received: January 9, 2009
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance high-energy phosphates and improve function following ischemia, states of congestive heart failure, and recently in subjects with lung disease. An initial preliminary, open label pilot study demonstrated a positive benefit of D-ribose in "Baby-Boomer" subjects aged 50 to 65 years old complaining of persistent fatigue. The objective of this study will build on the previously collected data to evaluate oral D-ribose vs. dextrose (administered as a supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state of fatigue.


Condition Intervention
Fatigue
Dietary Supplement: D-ribose
Dietary Supplement: Dextrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study

Resource links provided by NLM:


Further study details as provided by Bioenergy Life Science, Inc.:

Primary Outcome Measures:
  • CPX parameters relative to placebo as measured by: [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • VO2 at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Ventilation Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Oxygen Uptake Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Heart rate to METS ratio at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Net Energy Expenditure at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
A 6 gm/day (3 gm/bid) dose of D-ribose
Dietary Supplement: D-ribose
A 6 gm/day (3 gm/bid) dose of D-ribose in water. Each subject will consume oral D-ribose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
Placebo Comparator: 2
A 6 gm/day (3 gm/bid) dose of dextrose.
Dietary Supplement: Dextrose
A 6 gm/day (3 gm/bid) dose of dextrose in water. Each subject will consume oral dextrose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presents with complaint of fatigue with duration longer than one month
  • Males/Females between the ages of 50 and 65 years of age
  • No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history
  • Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods
  • Normal blood pressure or those with mild, untreated pre-hypertension (>120/70 or < 140/90 mmHg)
  • Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires
  • Must be able to understand the consent form, agree to participate, and to execute their signature

Exclusion Criteria:

  • Not presently taking any adenine nucleotide enhancing supplements
  • History of non-compliance in previous studies
  • Known to be pregnant
  • Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics
  • Moderate to severe gout
  • A diagnosis of arthritis of the lower extremities
  • Mental impairment, inability to cooperate
  • History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)
  • Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance
  • Any person who is incarcerated, or on a work release program

Additional Exclusions observed and sequelae during initial baseline evaluation:

  • Drop in systolic blood pressure of >10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia
  • Moderately severe angina
  • Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
  • Signs of poor perfusion (cyanosis or pallor)
  • Technical difficulties monitoring the ECG or systolic blood pressure
  • Subject's desire to stop
  • Sustained ventricular tachycardia
  • Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821067

Locations
United States, Colorado
Aurora Denver Cardiology Association
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Bioenergy Life Science, Inc.
  More Information

No publications provided

Responsible Party: Jeff Thompson, Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier: NCT00821067     History of Changes
Other Study ID Numbers: FS20081121
Study First Received: January 9, 2009
Last Updated: December 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014